Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Light, Ultraviolet, Dermatological
510(k) Number K861107
Device Name TAN MATE HOME TANNING UNIT
Applicant
SPECIALTY ENGINEERING, INC.
1766 EAST HIGHWAY 36
MAPLEWOOD,  MN  55109
Applicant Contact DAVID G PENNOCK
Correspondent
SPECIALTY ENGINEERING, INC.
1766 EAST HIGHWAY 36
MAPLEWOOD,  MN  55109
Correspondent Contact DAVID G PENNOCK
Regulation Number878.4630
Classification Product Code
FTC  
Date Received03/24/1986
Decision Date 04/25/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-